Safety/Tolerability and Efficacy of YHD001 in Patients With Acute and Chronic Bronchitis
Randomized, Double-blind, Placebo/Active-controlled, Multi-center, Phase 3 Clinical Trial to Investigate the Safety/Tolerability and Efficacy of YHD001 After Oral Administration in Patients With Acute or Chronic Bronchitis
1 other identifier
interventional
118
1 country
1
Brief Summary
The study will conduct with 4 comparative groups orally treated with YHD001 dose level 1(t.i.d.), YHD001 dose level 2(t.i.d.), pelargonium sidoides extract 9mL(t.i.d.) or Placebo for 7 days. The treatments will be assigned randomly to patients (n=116) with acute or chronic bronchitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Sep 2011
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 20, 2011
CompletedFirst Posted
Study publicly available on registry
August 19, 2011
CompletedStudy Start
First participant enrolled
September 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedSeptember 26, 2013
September 1, 2013
8 months
July 20, 2011
September 25, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Change of total symptom score from baseline to the end of treatment
7 days
Secondary Outcomes (3)
safety assessment
7 days
time to response
7 days
compliance, defined by drug accountability
7 days
Study Arms (4)
YHD001 dose level 1
EXPERIMENTALYHD001 dose level 1
YHD001 dose level 2
EXPERIMENTALYHD001 dose level 2
Pelargonium sidoides extract
ACTIVE COMPARATORPelargonium sidoides extract (Syrup)
Placebo
PLACEBO COMPARATORPlacebo for YHD001 \& active comparator(syrup)
Interventions
6-9mL three times daily / 7 days
Eligibility Criteria
You may qualify if:
- Male and female patients aged ≥18 year
- Provision of written informed consent
- Acute bronchitis with a Bronchitis Severity Score(BSS)≥five points
You may not qualify if:
- History of any clinically significant disease
- History of drug/chemical/alcohol abuse
- Use of antibiotics, anti-histamine during the 7 days before administration of the investigational product
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Catholic University of Korea Seoul St. Mary'S Hospital
Seoul, 137-701, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Young Kyoon Kim, M.D., Ph.D.
Division of Respiratory and Critical Care Medicine, Department of Internal Medicine, Seoul St. Mary's Hospital,College of Medicine, The Catholic University of Korea
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 20, 2011
First Posted
August 19, 2011
Study Start
September 1, 2011
Primary Completion
May 1, 2012
Study Completion
May 1, 2012
Last Updated
September 26, 2013
Record last verified: 2013-09